Caresite utilized in gravity IV administration sets and pump administration sets utilized with BBMI'
Pending LLM rewrite. Source: FDA_DEVICE Z-0624-2026.
Severity not yet assessed
We have not scored this recall against our rubric yet, so we are not showing a severity rating or our usual guidance. The agency’s own notice below is the authoritative source — read it first.
Plain-English summary
Potential for backflow of medication from secondary (piggyback) IV containers into primary IV containers and the inability to prime (occlusion).
The recalled product
- Product
- Caresite utilized in gravity IV administration sets and pump administration sets utilized with BBMI's Infusomat Space Large Volume Pump, Outlook Pump, and Vista Basic Pump. Labeled as the following with corresponding catalog numbers: 1. Primary Gravity IV Set with 2 CARESITE¿
- Manufacturer
- B Braun Medical Inc
- Category
- Medical Device — Devices
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (7)
- 1. Catalog Number: 354204
- Primary UDI-DI: 04046964182075
- Unit of Dose UDI-DI: 04046964182068. 2. Catalog Number: 354205
- Primary UDI-DI: 04046964182099
- Unit of Dose UDI-DI: 04046964182082. 3. Catalog Number: 354206
- Primary UDI-DI: 04046964182112
- Unit of Dose UDI-DI: 04046964182105.
Distribution
Distribution scope not specified by the agency.
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